Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Testing Kit on Colorectal Cancer Screening Rates

NCT ID: NCT05115916

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3880 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-28

Study Completion Date

2020-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Behavioral economics principles have increasingly been shown to improve health outcomes in the United States. They offer the ability to implement simple, low-cost and effective interventions to address key health issues without sacrificing the autonomy of patients. Colorectal cancer (CRC) screening is a key area where behavioral economics principles can help improve health outcomes. Despite being the second leading cause of cancer related death, the rate of CRC screening remains well below national targets. Interventions to address these issues, and improve screening rates at our institution have including implementing a Mailed FIT outreach program, and adding an informational letter that utilizes behavioral economic principles. To further improve our screening rates, this project builds upon our previous efforts to include a randomized electronic message primer via patients electronic patient portal, to help alert them of incoming FIT Kit and complete screening. This study will contribute to the growing literature of behavioral economics in medicine, while addressing an important health issue.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Colorectal cancer (CRC) is the second leading cause of death from cancers affecting both men and women in the United States. One in 17 Americans will suffer from CRC during his/her lifetime. Early detection by screening has been shown to reduce CRC mortality. Despite screening recommendations, the U.S. screening rate remains well below the national benchmark of 80% as established by the National Colorectal Cancer Roundtable. The U.S. Multi-Society Task Force (MSTF), however, does recommended FIT and colonoscopy as first line screening modalities for CRC in 2017. To help address the issue of suboptimal CRC screening, the investigators implemented an intervention utilizing the principles of behavioral economics to improve screening rates. Studies in behavioral economics and psychology indicate that how information or choice is framed impacts behavior in predictable ways, which has applications in health and medicine, including the design of CRC screening strategies. This project builds upon our institutions continued quality improvement efforts utilizing behavioral economics principles to improve CRC screening, through improving the choice architecture, framing and salience of information to incentivize routine screening.

For this project the investigators will leverage our electronic health records (EHR) patient portals to improve CRC screening. Specifically, the investigators developed an electronic primer within the EHR patient portal to alert patients due for CRC screening before arrival of a mailed FIT Kit. The investigators randomized implementation of the primer at the patient-level to determine whether the electronic primer improved CRC screening completion in patients enrolled in our mailed FIT program.

For our analysis, after summarizing our demographic data, the investigators plan to compare screening completion in the two study arms using an intention-to-treat analysis and t-tests. The investigators then plan a logistic regression and Cox proportional hazards model to compare time to screening utilization in the two study arms, controlling for age, sex, race, and ethnicity. Following this the investigators use Fisher's exact tests to compare completion of individual screening modalities in the two study arms. Lastly, the investigators plan a secondary, analysis to determine the impact of opening the portal message on screening utilization, using randomization arm as an instrumental variable. In this analysis the investigators compare the subset of patients in the intervention group that opened the portal primer message to the control group. P-values less than 0.05 are considered statistically significant.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer Colorectal Neoplasms Colorectal Cancer Screening

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Colorectal Cancer Screening Colon Cancer Nudge Behavior and Behavior Mechanisms Behavioral Economics Health Screening

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3880 patients 51-75 years old, within the UCLA Health Managed Care group overdue for average risk CRC screening without prior history of documented FIT or colonoscopy will be randomized into 2 groups, in a 1:1 ratio. The 2 groups represent standard of care, and then the MyChart Message group
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of Care

This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal)

Group Type NO_INTERVENTION

No interventions assigned to this group

MyChart Message

This group will receive a message via EHR portal informing them about the incoming FIT Kit

Group Type EXPERIMENTAL

MyChart Priming Message

Intervention Type BEHAVIORAL

In addition to the standard FIT mailer protocol, we will send randomized participants a message via their personal health portal. Patients receive the primer approximately 1-2 weeks prior to arrival of the FIT kit, which informed patients about the incoming FIT Kit and instructed patients to complete and return the kit promptly.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MyChart Priming Message

In addition to the standard FIT mailer protocol, we will send randomized participants a message via their personal health portal. Patients receive the primer approximately 1-2 weeks prior to arrival of the FIT kit, which informed patients about the incoming FIT Kit and instructed patients to complete and return the kit promptly.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Managed care patient, 51-75 years old
* Active primary care provider at UCLA seen within last 3 years

Exclusion Criteria

* Inactive MyChart status or mailing address at time of enrollment
* Died within follow up period
* Any high-risk features including first degree family members with CRC, personal history of adenomas, history of inflammatory bowel disease, and any genetic GI cancer syndromes.
* Exclusion from March 2020 cohort if received FIT mailer within past 6 months
Minimum Eligible Age

51 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UCLA Vatche and Tamar Manoukian Division of Digestive Diseases

UNKNOWN

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel M. Croymans, MD, MBA, MS

Medical Director, DOM Quality

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCLA Health Department of Medicine, Quality Office

Westwood, Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Goshgarian G, Sorourdi C, May FP, Vangala S, Meshkat S, Roh L, Han MA, Croymans DM. Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2146863. doi: 10.1001/jamanetworkopen.2021.46863.

Reference Type DERIVED
PMID: 35119462 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FITPrimer

Identifier Type: -

Identifier Source: org_study_id